267
Participants
Start Date
May 21, 2021
Primary Completion Date
August 6, 2024
Study Completion Date
August 6, 2024
Vestal DM Active device
Battery powered non-invasive neurostimulation device
Lifestyle modification
Subjects are prescribed a low calorie (500kcal deficit) diet if their BMI is ≥25. If a subject has a BMI of ≤24.9, they will be provided with guidance on ensuring their recommended daily dietary intake is achieved throughout the course of the trial (i.e 2,500kcal/day for men and 2,000kcal/day for women)
Vestal DM Sham device
Placebo comparator sham device (no active stimulation)
Icahn School of Medicine at Mount Sinai, New York
Charlottesville Medical Research Center, Charlottesville
Adult Medicine of Lake County, Mt. Dora
Oviedo Medical Research, Oviedo
New Med Research, Hollywood
South Florida Research Organization, Medley
University of Alabama, Birmingham
Complete Health Partners, Nashville
Billings Clinic, Billings
Biopharma Informatic, McAllen
Palm Research Center, Las Vegas
UC San Diego, Exercise and Physical Activity Resource Center, La Jolla
Northern California Research, Sacramento
ActivMed Practices & Research, Methuen
ActivMed Practices & Research, Portsmouth
St. Vincent's University Hospital, Dublin
Lead Sponsor
Collaborators (2)
University College Dublin
OTHER
CS Lifescience
UNKNOWN
Clinical Trial Mentors
INDUSTRY
Neurovalens Ltd.
INDUSTRY